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New hope for lung cancer: experimental drug RC148 takes on standard therapy

NCT ID NCT07416474

Disease control Sponsor: RemeGen Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study compares two treatments for people with advanced squamous non-small cell lung cancer who have not had prior therapy. Participants will receive either the experimental drug RC148 or the approved drug tislelizumab, both combined with chemotherapy. The goal is to see which combination works better at controlling the cancer and improving survival. About 574 adults aged 18-75 with good performance status are being recruited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 574 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily participate in the study and signed the Informed Consent Form (ICF). 2. Be willing to and able to participate in the trial and comply with the follow up procedures; 3. Male or female, aged 18-75 years. 4. Expected survival ≥ 3 months. 5. ECOG PS score 0 or 1. 6. Histopathologically or cytologically confirmed locally advanced or metastatic NSCLC not eligible for curative treatment. 7. No prior systemic anti-tumor treatment for advanced or metastatic squamous NSCLC. 8. Sufficient cardiac, bone marrow, hepatic, renal, and coagulation function. 9. Female participants must be postmenopausal, surgically sterilized, or of childbearing potential with a negative blood pregnancy test within 7 days before the first dose. Female participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate oocytes or breastfeed during this period. Male participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate sperm during this period. 10. At least one measurable lesion outside of the brain according to the RECIST v1.1 criteria. 11. A PD-L1 expression test report that meets the requirements must be provided before enrollment. Exclusion Criteria: 1. Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer. 2. Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist. 3. Presence of active brain metastases. 4. Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk. 5. Chest radiotherapy \> 30Gy within 6 months before randomization; palliative local treatment for non-target lesions within 2 weeks before randomization; non-specific immunomodulatory treatment within 2 weeks before randomization; Chinese herbal medicine or proprietary Chinese medicine treatment with anti-tumor indications within 1 week before randomization. 6. History of immunotherapy. Note: For adjuvant/neoadjuvant phases or curative radiotherapy/chemoradiotherapy, PD-L1/PD-1 antibody therapy should be administered only if recurrence or metastasis occurs more than 12 months after the completion of the last medication. 7. Prior systemic anti-tumor treatment other than chemotherapy and PD-1/PD-L1 antibodies. 8. Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks before randomization. 9. Use of any live or attenuated live vaccines within 4 weeks before randomization, or planned during the study. 10. Participation in other clinical trials within 4 weeks before randomization. 11. Major surgery, interventional therapy, or severe trauma within 4 weeks before randomization, or planned major surgery during the study; core needle biopsy or other minor surgery within 7 days before randomization. 12. Participants with history of severe coagulation dysfunction or current intake of anticoagulant drugs. 13. Toxic reactions from prior anti-tumor treatment have not recovered to grade 0-1 as defined by CTCAE version 6.0. 14. Severe acute or chronic infections. 15. Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 4 weeks before randomization; or presence of severe esophagogastric varices or epistaxis. 16. Severe arterial/venous thrombotic events or cerebrovascular accidents within 6 months before randomization. 17. Active or clinically significant heart disease. 18. Past or current interstitial lung disease, drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or clinical manifestations or high-risk factors suspected of interstitial lung disease. 19. History of gastrointestinal perforation and/or fistula, history of gastrointestinal obstruction within 6 months before randomization. 20. Presence of systemically diseases that are not stably controlled as judged by the investigator. 21. Active or history of autoimmune diseases with potential for recurrence. 22. Past history of other acquired or congenital immunodeficiency diseases or organ transplantation. 23. Known hypersensitivity or delayed-type hypersensitivity to certain components of the study drug or similar drugs. 24. Presence of symptomatic or intervention-requiring third-space effusions. 25. Other malignant tumors within 5 years before the start of study drug administration, except for malignant tumors that are expected to be cured after treatment. 26. Poor compliance and expected inability to cooperate with the completion of trial procedures. 27. Past or current history of any other diseases, abnormal physical examination findings, or abnormal laboratory examination findings that, in the investigator's judgment, reasonably suggest that the participant has a disease or condition unsuitable for the use of the study drug. 28. Local or systemic diseases not caused by malignant tumors, or diseases or symptoms secondary to tumors. 29. For participants who have used PD-1/L1 inhibitors, prior occurrence of grade 3 or above irAE related to immunotherapy, irAE leading to permanent discontinuation of treatment, grade 2 immune-related cardiotoxicity, or irAE of any grade involving the nervous system or eyes; prior occurrence of adverse events requiring treatment with immunosuppressive drugs other than corticosteroids, or recurrence of adverse events during previous immunotherapy requiring systemic use of corticosteroids again.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    78 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Xinjiang University

    RECRUITING

    Ürümqi, Xinjiang, China

  • Affiliated Hospital of Binzhou Medical University

    RECRUITING

    Binzhou, Shandong, China

  • Affiliated Hospital of Hebei University

    RECRUITING

    Baoding, China

  • Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, China

  • Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, China

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, Henan, China

  • Cancer Hospital Affiliated to Chongqing University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Cancer Hospital Affiliated to Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, China

  • Cancer Hospital Affiliated to Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Cancer Hospital Affiliated to Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, China

  • Cangzhou Central Hospital

    RECRUITING

    Cangzhou, China

  • Chongqing Medical University First Affiliated Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Dongguan People's Hospital

    RECRUITING

    Dongguan, Guangdong, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, Guizhou, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangmen Central Hospital

    RECRUITING

    Jiangmen, Guangdong, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Jiangsu Provincial People's Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, Liaoning, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, China

  • Nanyang Second People's Hospital

    RECRUITING

    Nanyang, Henan, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

  • Peking University Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Shenzhen People's Hospital

    RECRUITING

    Shenzhen, Guangdong, China

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Sun Yat-sen University First Affiliated Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, China

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Zhuhai, Guangdong, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangzhou, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, China

  • The First Affiliated Hospital of Lanzhou University

    RECRUITING

    Lanzhou, Gansu, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Wannan Medical College

    RECRUITING

    Wuhu, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Xinxiang, Henan, China

  • The First Affiliated Hospital of Zhengzhou

    RECRUITING

    Zhengzhou, Henan, China

  • The First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, China

  • The First People's Hospital of Chenzhou City

    RECRUITING

    Binzhou, China

  • The Fourth Affiliated Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army

    RECRUITING

    Xi'an, Shaanxi, China

  • The Second Affiliated Hospital of Army Medical University of the Chinese People's Liberation Army

    RECRUITING

    Chongqing, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The Second Affiliated Hospital of Guilin Medical University

    RECRUITING

    Guilin, Guangxi, China

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Tianjin Chest Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, China

  • Union Hospital Affiliated to Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technolo

    RECRUITING

    Wuhan, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, Jiangsu, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

  • Zhongda Hospital Affiliated to Southeast University

    RECRUITING

    Nanjing, Jiangsu, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, China

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Zhuzhou Central Hospital

    RECRUITING

    Zhuzhou, China

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